Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients

NCT03251963 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 100484
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to better understand how patient-level factors can be used to predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk reduction and minimize bleeding.

Conditions

Venous Thromboembolism; Deep Venous Thrombosis; Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Patients With in Range Initial Peak Xa Level

  Number of patients with in range initial peak Xa level

  36 hours

Secondary Outcomes (2)

• Number of Participants With Venous Thromboembolism Events or Death

  90 days

• Number of Participants With Bleeding Events

  90 days

Study Arms (2)

Fixed Dose Enoxaparin

EXPERIMENTAL

Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.

Drug: Fixed Dose Enoxaparin

Variable Dose Enoxaparin

EXPERIMENTAL

Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.

Drug: Variable Dose Enoxaparin

Interventions

Fixed Dose Enoxaparin DRUG

Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.

Fixed Dose Enoxaparin

Variable Dose Enoxaparin DRUG

Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.

Variable Dose Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• receiving Video-Assisted Thoracoscopic Surgery
• able to have Enoxaparin initiated within 8 hours after procedure

You may not qualify if:

• Contraindication to use of enoxaparin
• Intracranial bleeding/stroke
• Hematoma or bleeding disorder
• Heparin-induced thrombocytopenia positive
• Creatinine clearance less than or equal to 30 mL/min
• Serum creatinine greater than 1.6 mg/dL
• Epidural catheter

Sponsors & Collaborators

• University of Utah: lead
• University of Michigan: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• Pannucci CJ, Fleming KI, Varghese TK Jr, Stringham J, Huang LC, Pickron TB, Prazak AM, Bertolaccini C, Momeni A. Low Anti-Factor Xa Level Predicts 90-Day Symptomatic Venous Thromboembolism in Surgical Patients Receiving Enoxaparin Prophylaxis: A Pooled Analysis of Eight Clinical Trials. Ann Surg. 2022 Dec 1;276(6):e682-e690. doi: 10.1097/SLA.0000000000004589. Epub 2020 Oct 19.

  PMID: 33086312 DERIVED

• Pannucci CJ, Fleming KI, Bertolaccini C, Moulton L, Stringham J, Barnett S, Lin J, Varghese TK Jr. Fixed or Weight-Tiered Enoxaparin After Thoracic Surgery for Venous Thromboembolism Prevention. Ann Thorac Surg. 2020 Jun;109(6):1713-1721. doi: 10.1016/j.athoracsur.2019.12.058. Epub 2020 Feb 8.

  PMID: 32045583 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Christopher Pannucci
• Organization: University of Utah

christopher.pannucci@hsc.utah.edu

801 581 2121

Study Officials

• Christopher Puccini, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants enrolled in months 1-6 of the study will all receive a fixed dose of enoxaparin. Patients enrolled in months 7-12 of the study will all receive a variable dose of enoxaparin.

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: September 15, 2017
• Primary Completion: March 27, 2019
• Study Completion: July 27, 2019
• Last Updated: July 8, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-07

Locations

US (1)